Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy (RoboCUP)

Centre Francois Baclesse

Status and phase: Enrolling; Phase 2

Conditions: Cancer of Head and Neck; Adenopathy

Treatments: Procedure: tonsillectomy; Procedure: bilateral mucosectomy + tonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04767048

2020-A00947-32

Details and patient eligibility

About

We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with a prevalent head and neck lymphadenopathy with positive or non-contributory fine needle aspiration, or having had an adenectomy revealing a metastasis of squamous cell carcinoma, a PET examination, an injected cervico-thoracic CT and an ENT work-up (nasofibroscopy) not finding a primary tumor
• Performance Status < 2
• Patient aged 18 or over
• Patient affiliated with social security system
• Informed consent signed

Exclusion criteria

• History of squamous cell carcinoma of the VADS or skin of the face.
• History of cervico-facial radiotherapy
• Primary tumor discovering during pan-endoscopy
• Inexposable patient lead not to possible mucosectomy
• Uncontrollable hemostasis disorders (contraindication to tonsillectomy and basic bilateral mucosectomy of language)
• Distant metastases
• Lymphadenopathy inoperable
• Patient with a contraindication to radiotherapy
• Pregnant or breastfeeding woman
• Women of childbearing potential without effective contraception
• Patient under guardianship or unable to give informed consent
• Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)

Treatment:

Procedure: bilateral mucosectomy + tonsillectomy

Control Arm

Active Comparator group

Description:

Tonsillectomy alone (unilateral or bilateral at the choice of the investigator)

Treatment:

Procedure: tonsillectomy